An open label, multiple dose Phase III clinical study in patients with prostate cancer to investigate the clinical efficacy and safety of a new GnRH implant (AMW Goserelin 10.8 mg Implant) applied every 84 days for 168 days - AMW/002/C
- Conditions
- prostate cancer
- Registration Number
- EUCTR2010-018735-18-DE
- Lead Sponsor
- AMW GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Males aged 18 years or older
Histologically confirmed diagnosis of carcinoma of the prostate suitable for hormonal manipulation including patients with rising PSA after having undergone surgery or radiotherapy with curative intention
Normal testosterone values (> 2.3 ng/mL) at screening and baseline visit
Life expectancy of at least six months
The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form
The patient is able to understand and follow instructions and is able to participate in the study for the entire period
Patients must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Hypersensitivity to Zoladex® or to other GnRH analogues
Treatment with GnRH analogues in the last 12 months prior to the start of the study
Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion
Cancer disease within the last 5 years except prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin
Patients with clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or any infectious disorder or any other condition including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator
Mental incapacity or language barriers precluding adequate understanding or co-operation
Patients who have received an investigational drug within the last 12 weeks preceding Visit 1
Previous participation in this study
Simultaneous or less than 30 days earlier participation in another clinical trial
Known allergy against one of the ingredients in the test preparation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that the new AMW implant (AMW Goserelin 10.8 mg Implant leads to a consistent and clinically meaningful suppression of testosterone levels below castrate level (0.5 ng/ml) that can be maintained for the rest of the active treatment phase once it was achieved;Secondary Objective: Area-under-the-curve (AUC) of the testosterone levels on Days 28 to Days 168<br>percentage of patients who have reached castration level of testosterone (0.5 ng/mL) at the end of the study (Day 168),<br>the plasma/serum levels of goserelin and LH/FSH (Days 0, 1, 4, 14, 28, 42, 56, 70, 84, 85, 88, 98, 112, 126, 140, 154 and 168),<br>number of non-responders,<br>testosterone plasma levels on Days 0, 1, 4, 14<br>the results of the clinical examination of the prostate <br>assessment of safety and tolerability<br><br>;Primary end point(s): none
- Secondary Outcome Measures
Name Time Method